PO's & EDI, for the life of the part

L

LaurieB

#1
We are a manufacturer for the heavy truck industry. We receive many PO's through EDI transmission. These PO's have a qty, need date and part number. The information on them is very limited. Under record retention, will I be required to keep these for the life of the part + 1 year? I do not see this as a value added step, or something the customer would be willing to pay for. Any insight would be helpful (some products may be for 20+ years)
Laurie
 
Elsmar Forum Sponsor

Marc

Fully vaccinated are you?
Leader
#2
First of all, I want to apologise for not adressing this in some manner - seeing as it was posted on 3/22. I generally try to give some type of answer, but this forum has 'slipped by me'.

Any way.... The bottom line here is that the new QS requires POs be kept for the life of the part. The question is whether EDI transmissions from your customer to you are purchase orders. My reading says they are not. I consider EDI transactions to be scheduling documents derived from the original customer PO.

How about you other folks? Other opinions or, especially, direct experience from anyone else?
 
Thread starter Similar threads Forum Replies Date
U Automotive History Of Electronic Data Interchange (EDI) World News 3
Stijloor Updated EDI/XML Project Planner available from AIAG Misc. Quality Assurance and Business Systems Related Topics 0
W Has anyone implemented EDI in their organization? Misc. Quality Assurance and Business Systems Related Topics 14
B EDI back-up - Requirement for companies to have a full time EDI back-up? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
B EDI back-up QS-9000 - American Automotive Manufacturers Standard 1
G Epo-tek 301 shelf life extension Other Medical Device and Orthopedic Related Topics 0
T Determination of Software/system end-of-life IEC 62304 - Medical Device Software Life Cycle Processes 5
N Malaysia Shelf Life Change Other Medical Device Regulations World-Wide 2
N Class III PMA shelf life extension US Medical Device Regulations 2
J Using real time shelf life study as accelerated ISO 13485:2016 - Medical Device Quality Management Systems 1
D Class I Shelf-life requirements EU Medical Device Regulations 5
M Cosmetic Shelf Life Testing Misc. Quality Assurance and Business Systems Related Topics 10
N Shelf life guidance EU MDR, class 1 and class 2 Medical Devices EU Medical Device Regulations 2
G Verification of Expected Service Life: Max # Reprocessing Cycles IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
K Definition and Example of Shelf life, Expiry date, Expected service life and Lifetime EU Medical Device Regulations 6
D Shelf life of non sterile class IIb product. ISO 13485:2016 - Medical Device Quality Management Systems 1
G Lifecycle / Expected Service Life of Steel Parts Other Medical Device and Orthopedic Related Topics 5
Edward Reesor Class I non-sterile "Shelf Life" labeling (EU/UK) CE Marking (Conformité Européene) / CB Scheme 4
T Class III device and shelf life data requirements US Medical Device Regulations 7
P Demonstrate shelf life per ISO 11140-1 Other Medical Device Related Standards 0
R Shelf life of product Other Medical Device Related Standards 4
S Extending Shelf Life US Food and Drug Administration (FDA) 2
DuncanGibbons Safe-Life, Fail-Safe and Damage Tolerant approaches and their relevant material property requirements Federal Aviation Administration (FAA) Standards and Requirements 0
B Documenting Medical Device Complaints after End of Life? Medical Device and FDA Regulations and Standards News 0
W AS9100 Shelf Life Extension or Exemption AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
S Pharmaceutical Shelf Life Testing Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
L "Shelf-Life" Class I Non-Sterile Products Expiration Date? CE Marking (Conformité Européene) / CB Scheme 3
U EN 455-4 Accelerated Shelf Life tests for Medical Gloves Other Medical Device Related Standards 2
Q News cradle to grave - Product life cycle ISO 14001:2015 Specific Discussions 5
M Extension to shelf life of new product under MDR EU Medical Device Regulations 1
S Shelf Life Test for IFU and Implant Card Other Medical Device Related Standards 1
E Any sample of a full software life cycle IEC 62304 report ( any class )? IEC 62304 - Medical Device Software Life Cycle Processes 4
B Calibration in real life ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
T Sterilized components shelf life Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
L Shelf life of medical devices Other Medical Device Related Standards 4
U Does *anyone* know a lab that will test to EN 455-4 Medical Gloves shelf life determination? EU Medical Device Regulations 1
S How is the service life for class I reusable medical devices described in MDR? EU Medical Device Regulations 7
S How is the service life described for class I reusable medical devices in MDR? Elsmar Xenforo Forum Software Instructions and Help 1
C Shelf life electronic components 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
F Plastics cans shelf life determination under static load Manufacturing and Related Processes 1
D Question regarding ECO process, specifically for Life Science products and defining form fit and function ISO 13485:2016 - Medical Device Quality Management Systems 1
M Medical Devices Shelf Life ---INDIA Other Medical Device Regulations World-Wide 3
J Scope of ISO 9001 clause 10.2 in the product life cycle ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
D IEC 60601-1 - Service life testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
D Device functionality over service life - Objective evidence required? Design and Development of Products and Processes 10
Edward Reesor FDA DM and /or Class I Life Saving US Food and Drug Administration (FDA) 0
S Requirement to Conduct New Shelf-life Testing? (re-do testing for design change) EU Medical Device Regulations 3
M PPE shelf life Medical Device and FDA Regulations and Standards News 1
K EU Shelf life claims for individual materials EU Medical Device Regulations 2
K Product (Device) Life cycle - Product Life AFTER the Post Market Phase Medical Device and FDA Regulations and Standards News 3

Similar threads

Top Bottom